Specialized Experience

Legacy is experienced with developing all types of dosage forms for biopharmaceuticals, whether liquid, frozen, or lyophilized. Our approach is to use an iterative approach in order to evaluate a wide range of formulation space, thereby ensuring that the best formulation is identified. At the same time, the dataset that we generate for our clients allows them to pursue patent filings for the formulations that we develop. To date, Legacy has over fifty issued US patents assigned to our clients. In addition, we have worked on a wide range of specialized formulations, including in the following areas:

High Concentration Formulations: Employing a rational formulation design strategy, we can identify formulation conditions that increase solubility and lower viscosity for a variety of peptides and proteins.

Co-Formulations: We have experience with co-formulations of peptides and proteins, including monoclonal antibodies.

Vaccine Development: Legacy has a history of vaccine formulation development as well, encompassing multivalent, peptide-based, conjugate, and DNA-based vaccines.

Controlled Release Drug Delivery Systems: Our comprehensive experience spans a spectrum of controlled-released systems, encompassing polymeric microspheres, biocompatible gels, liposomes, suspensions, and devices. We have successfully incorporated antibiotics, chemotherapies, immune modulators, peptides, proteins, and DNA within these systems. Similarly, we have formulated biopharmaceuticals tailored for use in drug delivery devices, facilitating our ability to assist in the development of combination products.